CTRI/2013/12/004204招募中未知
A Feasibility Trial to Evaluate the Senseonics Continuous Glucose Monitoring System with Type - 2 Diabetes Patient. - SEUSMD
Senseonics Inc0 个研究点目标入组 20 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Age >= 18 to <= 65 years at screening
- •2. Clinically confirmed diagnosis of Type 1 diabetes mellitus (for at least I year of duration on multiple daily injections ( >2 injections per day) or on insulin pump therapy.
- •3. Subject understands study procedures and risks, is willing to comply with protocol requirements, and has signed an informed consent document.
- •4. HbA1c <= 10%
排除标准
- •1. History of severe hypoglycemia in the 6 months immediately prior to study start.
- •2. Severe diabetic Ketoacidosis in the past 6 months.
- •3. Females who are lactating, pregnant or intending to become pregnant during the course of the investigation.
- •4. Any condition preventing or complicating the placement, operation or removal of the Sensor.
- •5. Any medical condition or illness that in the judgment of the investigator might interfere with the procedures, results or compliance during the course of this investigation, or increase the risk of induced hypoglycemia or repeated blood testing.
- •6. Known microvascular (diabetic) complications (other than non-proliferative retinopathy), including active proliferative diabetic retinopathy or macular edema, non-proliferative retinopathy stage 3, diabetic nephropathy (other than microalbuminuria with normal creatinine), gastroparesis or neuropathy requiring treatment.
- •7. Currently receiving any of the following therapies, or likely to need such treatment during the follow-up period of this study:
- •Immunosuppressant therapy
- •Chemotherapy for any form of cancer
- •Anti-coagulant therapy (e.g. Plavix, LMW heparin, coumadin)
- •8. Magnesium <1.6 mg/dL at screening.
- •9. Potassium <3.4 mmol/L at screening.
- •10. Hematocrit >50% or <30% at screening.
- •11. Topical or local anesthetic allergy.
- •12. Known current or recent alcohol or drug abuse by Subject history.
- •13. Participation in another clinical investigation within 30 days preceding screening, or intention to participate in any other clinical investigation during the period of this study.
- •14. The presence of any other active implanted device, whether turned on or off. Passive implants are allowed.
- •15. A condition requiring or likely to require the use of magnetic resonance imaging (MRI).
- •16. Positive drug screen results
- •17. Any condition that in the investigatorâ??s opinion would make the Subject unable to complete the study. Investigator will supply rationale.
研究者
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